PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534859

Acronym

PROTECT I

Enrollment

Registered

2007-09-26

Start date

2006-08-31

Completion date

2011-03-31

Last updated

2011-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing High Risk PCI.

Brief summary

The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.

Interventions

DEVICEHigh Risk PCI

High Risk Percutaneous Coronary Intervention

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Signed Informed Consent * Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft * EF \<35%

Exclusion criteria

* ST Myocardial Infarction * Cardiac Arrest * Cardiogenic Shock * Thrombus Left Ventricle

Design outcomes

Primary

Measure	Time frame	Description
MACCE Events at 30 days or discharge, whichever is longer	30 days or discharge	Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.
Freedom from Hemodynamic compromise during PCI procedure	During procedure	Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required

Secondary

Measure	Time frame	Description
Other intra-procedural and peri-procedural adverse events	During treatment and out to 90 days	—
Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion	During procedure	Freedom from the following procedural-related events: i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion
Angiographic Success	Post-PCI	Angiographic success defined as residual stenosis \<30% after stent implantation or \<50% after balloon angioplasty.

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026